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Sleep ApneaPhase 4NCT00424658

Sleep Apnea. Concordance Between Non-reference and Reference Centres

A Phase 4 study testing SAHS diagnosis in people with Sleep Apnea, run by Hospital Clinic of Barcelona at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

When a disorder is as prevalent as sleep apnea hypopnea syndrome various medical levels and strategies should be implicated. We to evaluate the degree of concordance in management between a sleep reference centre and non-reference centres. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Sleep Apnea
What is being tested?
SAHS diagnosis
Type of treatment
Surgery or procedure
How many people
90 participants
Where
2 sitesSpain
Study dates
Jan 2000to Apr 2004
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Supected sleep apnea

Who cannot join

  • Major diseases

Trial locations and contacts

2 sites in 1 country.

Spain2 sites
  • Hospital Clinic. Fundacio Clinic.IDIBAPS

    Barcelona, 08036

  • Hospital Clinic.Fundacio Clinic.IDIBAPS

    Barcelona, 08036

Other trials in Spain

About this study

When a disorder is as prevalent as sleep apnea hypopnea syndrome various medical levels and strategies should be implicated. We to evaluate the degree of concordance in management between a sleep reference centre and non-reference centres.

Read the detailed description

INTRODUCTION: When a disorder is as prevalent as SAHS, different medical levels should be involved to facilitate diagnosis for all patients, or at least those that are in moderate-severe or risk groups. A good option could be to transfer the patient assessment to non-reference centres (NRC). Therefore, the aim of the present study was to evaluate this strategy by analysing the degree of concordance between RC and NRC in treatment decision and management of SAHS patients.

MATERIALS AND METHODS: Study subjects: The study population consisted of 88 consecutive subjects with a suspicion of SAHS (age 50±11 years, 81 % male, BMI 30±4 K/m2) from the out-patient clinics of three NRC in the Barcelona area: Hospital Asil de Granollers, Hospital General de Vic and Hospital de Terrassa.

Study design: The patients were evaluated independently, at random, over the course of 1 month in the RC and NRC. In both types of centre, the patient evaluation was carried out on the basis of the clinical history, with a specific questionnaire about sleep disordered breathing, and a sleep study in the hospital. The evaluation was performed by a sleep physician in the RC and by a respiratory physician with training in sleep medicine in the NRC. In both cases, the choice of treatment was registered on an ordinal scale with four points: 1= No diagnosis of SAHS and patient is discharged; 2= Mild SAHS, patient should follow a conservative treatment and clinical control; 3= Moderate to severe SAHS, patient should begin continuous positive air pressure (CPAP) treatment; 4= Other sleep disorders are diagnosed (RC), or there is a need for full-night PSG owing to a discordance between clinical features and respiratory polygraphy in NRC. The indication for CPAP treatment followed the national-SEPAR guidelines summarized as: 1) Patients with severe SAHS-related symptoms with an AHI>10; or 2) Patients with mild to moderate clinical symptoms with an AHI>30. The human ethics committee of our hospital approved the protocol and informed consent was obtained from all the patients. Sleep studies: Reference hospital: Full-night polysomnography was performed in the usual manner. Briefly, the variables registered were electroencephalogram, chin electromyogram, electro-oculogram, tibial electromyogram, arterial oxygen saturation, ribcage and abdominal motion and their sum. Airflow was measured by cannula/thermistor. An apnea was defined as the absence or airflow equal to or greater than 10 seconds. Hypopnoea was defined by any discernible reduction in the amplitude of the airflow signal ending in an arousal and/or association with a 3% desaturation, with a duration of at least 10 seconds. An expert technician scored sleep stages and respiratory variables manually. An apnea-hypopnoea index (AHI) equal to or greater than 10 was considered abnormal.Non-reference centres: patients received a respiratory poligraphy with recording of body position, ribcage and abdominal motion, snoring, arterial oxygen saturation and airflow using a cannula/thermistor. The respiratory physician performed a manual scoring of the recording. The definitions of hypopnoea and apnea resembled those mentioned above, except in the case of arousal. Data analysis: Data were entered using SPSS 10.0 and imported to STATA 7.0 to perform the analysis (StatatCorp. 1999. Stata Statistical software: Release 7.0. College Station, TX: Stata Corporation). Descriptive analysis: Data were expressed as mean ± SD or percentage for quantitative and qualitative variables, respectively. For continuum variables, a logarithmic transformation was undertaken to normalise the distribution, if necessary. If the distribution was not symmetrical, data were expressed as percentiles. Concordance analysis: Evaluation of the concordance of the final outcome and the choice of treatment, between the RF and the NFC centres, was performed by using the statistic Kappa balanced, penalizing extreme discrepancies, following the classification of Landis \& Koch (25). This procedure was also used for the concordance in the result of the AHI of the sleep study, categorised as follows: <10, 10-29, ≥30. Concordance in the results of the sleep study (AHI and CT90) was evaluated in accordance with the Band \& Altman methodology and the concordance coefficient of Lin.

Conditions
Sleep Apnea
Being tested
SAHS diagnosis
Keywords
breathing disorders
Medical subject headings
Sleep Apnea Syndromes, Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAHS diagnosisProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Concordance in sleep apnea management between reference vs non reference centres

Secondary outcomes (1)
  1. Concordane betwen polysomnographic data

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2007 (estimated)
  2. Study startJan 2000
  3. Study completionApr 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Enrolment
90 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00424658
Sponsor's protocol ID
Sleep concordance
Status last verified
Jan 2007
First submitted
17 Jan 2007
Last updated
1 Apr 2015
Results posted
No

Publications

  • Hernandez L, Torrella M, Roger N, Llunell A, Ballester E, Quinto L, Serrano M, Masa F, Montserrat JM. Management of sleep apnea: concordance between nonreference and reference centers. Chest. 2007 Dec;132(6):1853-7. doi: 10.1378/chest.07-0250. Epub 2007 Oct 9.

    PubMed 17925431

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing SAHS diagnosis in people with Sleep Apnea, run by Hospital Clinic of Barcelona at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concordance in sleep apnea management between reference vs non reference centres. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00424658, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.

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